Real-world analysis suggests 3.2-month
survival benefit for individuals treated with RADICAVA and riluzole
compared to those treated with only riluzole
No new safety concerns in final results
from long-term Phase 3 safety extension study in RADICAVA
ORS® (edaravone)
JERSEY
CITY, N.J., June 17,
2024 /PRNewswire/ -- Mitsubishi Tanabe Pharma
America, Inc. (MTPA) today announced results from two studies of
RADICAVA® (edaravone) for amyotrophic lateral sclerosis
(ALS) at the European Network to Cure Amyotrophic Lateral Sclerosis
(ENCALS) 2024 meeting. Findings from an ongoing real-world study
utilizing information in the ALS/MND Natural History Study
Consortium (Consortium) database of people living with ALS
initiating treatment with RADICAVA suggest an additional survival
benefit of 3.2 months with RADICAVA ± riluzole compared to
treatment with riluzole alone. Separately, positive results from
Study MT-1186-A03 (NCT04577404), a Phase 3 study evaluating the
long-term safety of RADICAVA ORS® (edaravone), showed no
new safety concerns and that RADICAVA ORS was well-tolerated during
the 96-week study period.
"Access to real-world data is critical for complex rare diseases
like ALS, and we are proud to collaborate with the ALS/MND
Consortium to bring important real-world insights to the clinical
community," said Gustavo A. Suarez
Zambrano, M.D., Vice President of Medical Affairs at MTPA.
"In addition, we are encouraged that our long-term Phase 3 safety
extension study continues to demonstrate the safety and
tolerability profile of RADICAVA."
Poster Presentation: Treatment Patterns and Survival
Benefit of Edaravone–Treated People with Amyotrophic Lateral
Sclerosis in the ALS/MND Natural History
Consortium
The ongoing real-world study evaluated
treatment patterns, clinical outcomes, and survival of
RADICAVA–treated people living with ALS from the ALS/MND NHC
database. Individuals receiving RADICAVA ± riluzole (n=176) were
matched to those receiving riluzole only (n=176) based on a variety
of factors, including their baseline mean ± standard deviation (SD)
ALS Functional Rating Scale-Revised score (39.5±4.8 and 39.3±4.8,
respectively). The safety profile of RADICAVA ORS was demonstrated
in a 6-month, Phase 3, open-label clinical trial in 185
patients.1 In addition to contusion, gait
disturbance, and headache reported with RADICAVA, fatigue was
observed in 7.6% (14/185) of patients receiving RADICAVA
ORS.1 Please see Important Safety Information below
and Full Prescribing Information here.
Restricted mean survival time (RMST) analyses over 50 months
suggested a survival benefit for individuals receiving RADICAVA ±
riluzole (31.1 months) versus those receiving riluzole only (28.8
months), without adjustment for baseline covariates. RMST
difference between treatment groups was 3.2 months (p<0.03)
after adjustment for covariates.
"Through our collaboration with MTPA, we are thrilled to
highlight initial results from a real-world analysis of people
living with ALS in our database," said Alex
Sherman, Director of the Center for Innovation and
Biomedical Informatics (CIB) at the NCRI at MGH and Principal
Investigator for the study. "Together, our real-world findings
underscore our continued commitment to improving outcomes and
building confidence in existing treatment options for the ALS
community. We hope to build this momentum as our analysis of
treatment patterns in the database continues."
Poster Presentation: Phase 3, Open-Label, Safety
Extension Study of Oral Edaravone Administered Over 96 Weeks in
Patients with ALS (MT-1186-A03)
Study
MT-1186-A03 was a Phase 3, open-label, multi-center, extension
study that evaluated the long-term safety of RADICAVA ORS over an
additional 96 weeks in patients who have completed the initial 48
weeks of Study MT-1186-A01. Participants received RADICAVA ORS
(105-mg dose) according to the FDA-approved dosing. Patients had
definite, probable, probable-laboratory-supported, or possible ALS;
baseline forced vital capacity ≥70%; and baseline disease duration
≤3 years.
In the study, the most common treatment-emergent adverse events
(TEAEs) were fall, muscular weakness, dyspnea, constipation, and
dysphagia. These TEAEs were consistent with the safety profile for
edaravone from previous clinical trials.
About RADICAVA® (edaravone) and RADICAVA
ORS® (edaravone)
The U.S. Food and Drug Administration (FDA) approved
RADICAVA® (edaravone) on May
5, 2017, and the oral formulation RADICAVA
ORS® (edaravone) on May 12, 2022, for the treatment of amyotrophic
lateral sclerosis (ALS). In 2024, the FDA recognized RADICAVA ORS
with Orphan Drug Exclusivity based on the major contribution to
patient care of the innovative oral formulation. RADICAVA is
administered in 28-day cycles by intravenous (IV) infusion. It
takes 60 minutes to receive each 60 mg dose. For the initial cycle,
the treatment is infused daily for 14 consecutive days, followed by
a two-week drug-free period. All cycles thereafter are infused
daily for 10 days within a 14-day period, followed by a two-week
drug-free period. RADICAVA ORS is taken daily for 14 consecutive
days followed by a 14-day drug-free period for the initial
treatment cycle. For subsequent treatment cycles, RADICAVA ORS is
taken for 10 days within a 14-day period followed by a 14-day
drug-free period. RADICAVA ORS should be taken in the morning
after overnight fasting. Patients should not eat or drink (except
water) within one hour after taking RADICAVA ORS.1
Edaravone was discovered and developed for ALS by Mitsubishi
Tanabe Pharma Corporation (MTPC) and commercialized in the U.S. by
Mitsubishi Tanabe Pharma America, Inc. (MTPA). The MTPC group
companies began researching ALS in 2001 through an iterative
clinical platform over a 13-year period. In 2015, edaravone was
approved as RADICUT® for the treatment of ALS in
Japan and South Korea. Marketing authorizations were
subsequently granted in Canada
(October 2018), Switzerland (January
2019), Indonesia
(July 2020), Thailand (April
2021), Malaysia
(December 2021) and Brazil (February
2024). Marketing authorization for RADICAVA® Oral
Suspension was granted in Canada
(November 2022) and Switzerland (May
2023), and RADICUT® Oral Suspension 2.1% was
granted regulatory approval in Japan in December
2022. To date, in the U.S., RADICAVA and RADICAVA ORS have
been used to treat over 16,000 people with ALS, with over
1.9-million days of therapy, and have been prescribed by over 2,400
HCPs.2-4
IMPORTANT SAFETY INFORMATION
Hypersensitivity Reactions
RADICAVA (edaravone) and RADICAVA ORS (edaravone) are
contraindicated in patients with a history of hypersensitivity to
edaravone or any of the inactive ingredients of this product.
Hypersensitivity reactions (redness, wheals, and erythema
multiforme) and cases of anaphylaxis (urticaria, decreased blood
pressure, and dyspnea) have occurred with RADICAVA.
Patients should be monitored carefully for hypersensitivity
reactions. If hypersensitivity reactions occur, discontinue
RADICAVA or RADICAVA ORS, treat per standard of care, and monitor
until the condition resolves.
Sulfite Allergic Reactions
RADICAVA and RADICAVA ORS
contain sodium bisulfite, a sulfite that may cause allergic-type
reactions, including anaphylactic symptoms and life-threatening or
less severe asthmatic episodes in susceptible people. The overall
prevalence of sulfite sensitivity in the general population is
unknown but occurs more frequently in asthmatic people.
Adverse Reactions
The most common adverse reactions (≥10%) reported in
RADICAVA-treated patients were contusion (15%), gait disturbance
(13%), and headache (10%). In an open label study, fatigue was also
observed in 7.6% of patients receiving RADICAVA ORS.
Pregnancy
Based on animal data, RADICAVA and RADICAVA
ORS may cause fetal harm.
To report suspected adverse reactions or product complaints,
contact Mitsubishi Tanabe Pharma America, Inc., at 1-888-292-0058.
You may also report suspected adverse reactions to the FDA at
1-800-FDA-1088 or www.fda.gov/medwatch.
INDICATION
RADICAVA and RADICAVA ORS are indicated for
the treatment of amyotrophic lateral sclerosis (ALS).
For more information, including full Prescribing Information,
please visit www.RADICAVA.com.
About Mitsubishi Tanabe Pharma America,
Inc.
Based in Jersey City,
N.J., Mitsubishi Tanabe Pharma America, Inc. (MTPA) is a
wholly-owned subsidiary of Mitsubishi Tanabe Pharma Corporation
(MTPC). It was established by MTPC to develop and advance our
pipeline as well as commercialize approved pharmaceutical products
in North America. For more
information, please visit www.mt-pharma-america.com or follow us
on X (formerly Twitter), Facebook and LinkedIn.
About Mitsubishi Tanabe Pharma Corporation
Mitsubishi Tanabe Pharma Corporation (MTPC), the pharma arm of
Mitsubishi Chemical Group (MCG), is one of the oldest
pharmaceutical companies in the world, founded in 1678. MTPC is
headquartered in Doshomachi, Osaka, the birthplace of Japan's pharmaceutical industry. MCG has
positioned health care as its strategic focus in its management
policy, "Forging the future". MTPC sets the MISSION of "Creating
hope for all facing illness". To that end, MTPC is working on the
disease areas of central nervous system, immuno-inflammation,
diabetes and kidney, and cancer. MTPC is focusing on "precision
medicine" to provide drugs with high treatment satisfaction and
additionally working to develop "around the pill solutions" to
address specific patient concerns based on therapeutic medicine,
including prevention of diseases, pre-symptomatic disease care,
prevention of aggravation and prognosis. For more information, go
to https://www.mt-pharma.co.jp/e/.
Media inquiries:
Media_MTPA@mt-pharma-us.com
1 RADICAVA and RADICAVA ORS Prescribing
Information. Jersey City, NJ:
Mitsubishi Tanabe Pharma America, Inc.; 2022.
2 Data on file. Mitsubishi Tanabe Pharma America,
Inc.
3 Data on file. Mitsubishi Tanabe Pharma America,
Inc.
4 Data on file. Mitsubishi Tanabe Pharma America,
Inc.
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